Dechra Pharmaceuticals PLC
Automation and Calibration Manager
Dechra Pharmaceuticals PLC, Pomona, California, United States, 91768
Vacancies
Automation and Calibration Manager
Job Introduction
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships and ( A )mbition are at the heart of our everyday operations and the way we do business.
The Opportunity
Responsible for leading and coordinating the execution of preventative and corrective maintenance, programming, and calibration of the Company's instrumentation and automation assets to achieve targeted reliability, equipment OEE, and ensuring compliance with cGMP requirements.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
Performs installation, preventive maintenance, troubleshooting and repair of all automation system controls in pharmaceutical manufacturing facility. Lead and/or guide Automation & Calibration Problem Solving and troubleshooting to identify root cause; develop timely solutions; participate in execution of work as needed; and communicate outcomes to all interested parties. Perform and approve actions related to the Computerized Maintenance Management System (CMMS) as required. Performs inspections to determine the reparability of existing automation systems, schedules repairs as needed, and develops an asset retirement and replacement strategy. Manage inventory of spare parts required for the equipment controls and maintain the storage of the equipment PLC programs ensuring spend is controlled within budget and critical spares are readily available. Work with the Planner/Buyer to optimize the spare parts sourcing network and supplier relations contracts to deliver cost efficiencies. Performs gap analyses for the automation equipment used in the current production processes and identifies opportunities for implementation of automation and controls in the production lines to improve operational efficiency. Initiates change controls for replacement or modification of the equipment control systems and writes User Requirement Specifications. Responsible for preparing Functional Requirements Specification and Functional Design Specification for new automated systems. Provides technical support in validation of the control systems. Manage calibration resources to ensure work is performed timely, professionally, and according to cGMP requirements. Managing, motivating, mentoring, and engaging the calibration team to deliver a valued service to their customers; consistently high standards at the right cost; and promote a "can do" attitude both individually and as a team. Complete all Dechra people management activities and identify appropriate development activities for assigned staff. Manage relationships with contractors and service providers. Take accountability for budgetary control, optimizing spend in assigned area of responsibility. Ensure full compliance with site Standard Operating Procedures and applicable regulatory requirements, and that tasks are performed in accordance with cGMP, EHS, loss prevention Company processes. Investigate and document quality events related to automation controls and calibration of equipment. Provide regular updates and reports to demonstrate calibration team performance against identified objectives and identify potential challenges.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are: Bachelor's degree in engineering, computer science, or closely related discipline required. Higher-level degree in engineering or closely related discipline and/or professional certification in electrical, automation, or controls system engineering desirable. Minimum 5 years of practical experience as automation or system controls engineer for machinery in a pharmaceutical setting. Minimum of 3 years of experience in managing a team of technicians. Experience with application of LEAN/six-sigma tools and principles. Experience working in multi-cultural environments with direct reports and knowledge and application of ISO14001, OHSAS18001, ISO 9001 standards are all desirable. Maintenance and repair of system controls for filling and packaging equipment used in cGMP environment. Installation and programming of newer and older types of Allen Bradley PLCs including HMI units. Ability to understand electrical and pneumatic controls used in filling and packing equipment. Extensive knowledge in the calibration processes of production equipment and laboratory instruments used in pharmaceutical or medical industries. Understanding of FDA regulations for computerized systems and 21 CFR Part 11 Compliance. Strong people management and development skills. Leading teams and managing multiple objectives and tasks in a fast-paced environment. Compliance mindset with a working knowledge of applicable Quality and EHS regulations. Proven technical writing ability to document cGMP changes, investigations, etc. Computer literate with proficiency in Microsoft Excel, Word, Power Point, and Project. Proficient/fluent in English. Fully bilingual English/Spanish desirable. Strong written and verbal communication skills; ability to engage effectively with a variety of stakeholders.
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work. #J-18808-Ljbffr
Automation and Calibration Manager
Job Introduction
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships and ( A )mbition are at the heart of our everyday operations and the way we do business.
The Opportunity
Responsible for leading and coordinating the execution of preventative and corrective maintenance, programming, and calibration of the Company's instrumentation and automation assets to achieve targeted reliability, equipment OEE, and ensuring compliance with cGMP requirements.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
Performs installation, preventive maintenance, troubleshooting and repair of all automation system controls in pharmaceutical manufacturing facility. Lead and/or guide Automation & Calibration Problem Solving and troubleshooting to identify root cause; develop timely solutions; participate in execution of work as needed; and communicate outcomes to all interested parties. Perform and approve actions related to the Computerized Maintenance Management System (CMMS) as required. Performs inspections to determine the reparability of existing automation systems, schedules repairs as needed, and develops an asset retirement and replacement strategy. Manage inventory of spare parts required for the equipment controls and maintain the storage of the equipment PLC programs ensuring spend is controlled within budget and critical spares are readily available. Work with the Planner/Buyer to optimize the spare parts sourcing network and supplier relations contracts to deliver cost efficiencies. Performs gap analyses for the automation equipment used in the current production processes and identifies opportunities for implementation of automation and controls in the production lines to improve operational efficiency. Initiates change controls for replacement or modification of the equipment control systems and writes User Requirement Specifications. Responsible for preparing Functional Requirements Specification and Functional Design Specification for new automated systems. Provides technical support in validation of the control systems. Manage calibration resources to ensure work is performed timely, professionally, and according to cGMP requirements. Managing, motivating, mentoring, and engaging the calibration team to deliver a valued service to their customers; consistently high standards at the right cost; and promote a "can do" attitude both individually and as a team. Complete all Dechra people management activities and identify appropriate development activities for assigned staff. Manage relationships with contractors and service providers. Take accountability for budgetary control, optimizing spend in assigned area of responsibility. Ensure full compliance with site Standard Operating Procedures and applicable regulatory requirements, and that tasks are performed in accordance with cGMP, EHS, loss prevention Company processes. Investigate and document quality events related to automation controls and calibration of equipment. Provide regular updates and reports to demonstrate calibration team performance against identified objectives and identify potential challenges.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are: Bachelor's degree in engineering, computer science, or closely related discipline required. Higher-level degree in engineering or closely related discipline and/or professional certification in electrical, automation, or controls system engineering desirable. Minimum 5 years of practical experience as automation or system controls engineer for machinery in a pharmaceutical setting. Minimum of 3 years of experience in managing a team of technicians. Experience with application of LEAN/six-sigma tools and principles. Experience working in multi-cultural environments with direct reports and knowledge and application of ISO14001, OHSAS18001, ISO 9001 standards are all desirable. Maintenance and repair of system controls for filling and packaging equipment used in cGMP environment. Installation and programming of newer and older types of Allen Bradley PLCs including HMI units. Ability to understand electrical and pneumatic controls used in filling and packing equipment. Extensive knowledge in the calibration processes of production equipment and laboratory instruments used in pharmaceutical or medical industries. Understanding of FDA regulations for computerized systems and 21 CFR Part 11 Compliance. Strong people management and development skills. Leading teams and managing multiple objectives and tasks in a fast-paced environment. Compliance mindset with a working knowledge of applicable Quality and EHS regulations. Proven technical writing ability to document cGMP changes, investigations, etc. Computer literate with proficiency in Microsoft Excel, Word, Power Point, and Project. Proficient/fluent in English. Fully bilingual English/Spanish desirable. Strong written and verbal communication skills; ability to engage effectively with a variety of stakeholders.
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work. #J-18808-Ljbffr